This invention relates to providing a medical system assisting more efficient and safer performance of medical procedures. More particularly, this invention concerns a medical system comprising apparatus and methods for improved irrigation and lavage. With respect to irrigation problems, when a patient has a wound, it is desirable to irrigate the wound with a solution such as normal saline. Presumably the dilution effect of the irrigation will wash out bacteria and debris and prevent wound contamination, infection and scarring. The more fluid, the greater the degree of success in prevention. A higher pressure of irrigation could also help remove bacteria and push out unwanted debris. Unfortunately, when using large volumes or high amounts of pressures, there is a high likelihood of contaminated fluid spreading to unwanted surfaces, including splashing onto a health care provider or drenching the patient. This is undesirable as the risk of spreading of disease is heightened and there are undesirable effects of getting a patient wet (for example, a trauma patient with multiple wounds might be hypothermic from a large amount of irrigation fluid evaporating on his body, or a child with a facial laceration might become hypothermic from the excess fluid wetting its clothing during the winter). The excess fluid will also soil laundry and require increased housekeeping services, using existing methods of irrigation. This is also an inconvenience for otherwise healthy patients. They may have to remove their clothing to prevent them from getting soaked. This may be uncomfortable for the patient in a busy emergency room; and the time necessary for the patient to disrobe would delay a doctor's or nurse's ability to treat such patient or other waiting patients more expeditiously. These disadvantages will decrease the incentive for an operator, such as a physician, to appropriately use optimal large volumes of irrigation fluid; and therefore the risk of wound complications will increase.
Wound irrigation shields with a circular flat surface are non-conforming to most body surfaces that sustain lacerations, since the more commonly lacerated surfaces are on an edge or ridge or prominence rather than a flat surface (e.g., portions of arms or fingers, etc.). So use of such shields typically leaves open gaps where fluid can spray out and contaminate the nearby regions. Since the flat base surface of such devices can only be used in one plane when the base is placed with stability against the skin for support, a user is encouraged to use only the perpendicular-to-the-skin spray orientation that the device provides, rather than angling the device in non-perpendicular orientations. It is noted, and it is an object and feature of this invention, that angling the spray would allow visualization from directly above—where the operator is most likely going to be looking from and where his/her viewpoint is more likely to be.
Another problem with a generally perpendicular angle of an irrigation jet is that this configuration tends to push wound bacteria or debris straight down and deeper into the wound. As an object and feature of this invention, angling the irrigation jet gives a horizontal vector to the forces on the bacteria and debris within the wound and this tends to push the debris out of the wound rather than just farther into it. It could push the debris out of a wound by sometimes aiming the flow underneath the target and thus pushing it up by the upwelling of the irrigation fluid rather than jamming it farther in.
Nor does the prior art (in using such “perpendicular” splash shields) teach efficient removal of large amounts of irrigating fluid. Typically, at present, workers must mop up the blood-tinged irrigation fluids with sheets and towels, with associated increased hospital wastes and costs and increased biohazard risks to hospital personnel, including risk of slipping on a wet floor, for example. If a wound irrigation shield has a suction irrigation-removal system has a suction coaxially placed with the irrigation unit, this will distort the irrigation stream; in fact, if the forces of the stream are small and the vacuum of the removal system is great, there may not be enough force for the stream to reach the wound. Further, if the removal outlet is high above the surface of the patient, it is less effective in suctioning fluid on a patient's body surface since it would have to have a strong vacuum to pull the irrigation fluid off the body up into the air and into the vacuum outlet. Thus it would be beneficial, and it is an object and feature of this invention to provide a more efficient system and means for wound irrigation and irrigating-fluid removal.
Further objects and features of my invention are not taught in the prior art. There is no teaching of a wound splash shield device with an irrigation fluid jet that can be activated by suctioning or siphoning that provides an automatic irrigation stream that can deliver high volumes of irrigation; nor is there any teaching of a wound splash shield device with an irrigation fluid jet that can be activated by suctioning or siphoning that requires fluid to traverse a wound before reaching an outlet that provides an automatic irrigation stream that can deliver high volumes of irrigation fluid to cleanse the wound with minimal effort and also providing an effective removal means of this irrigation fluid. Nor is there teaching of this fluid, once activated, having a continual non-automatic stream powered by a continued suctioning or siphoning effect; nor is there teaching of such a device also having a flexible catheter attached to an inlet for suctioning or siphoning or such a device also being capable of accommodating a more active irrigation fluid delivery device such as a syringe to the same port or another port to enable one device to be capable of a variety of irrigation delivery techniques.
As most wounds are linear (or a combination of linear openings in the skin), the rounded lateral surfaces are generally wasted space that, as mentioned above, can actually be detrimental to optimal performance. There is no teaching in prior art of wound splash shields, as in a feature of my inventions, with a more elongated opening or base, which would be better suited for most wound surfaces, to economize space and prevent the outpouring or spraying of debris and contaminated fluid. Nor is there teaching in prior art of wound splash shields with a contoured opening or base that would be better suited for most wound surfaces on body prominences to perform a better effective seal to improve the activation or operation of a suction- or siphon-controlled splash shield.
In addition, when an operator empties a syringe using the described prior art splash shield, the operator must actively detach the shield from the syringe. This active step is one more that will discourage a user who, for example, is in a busy emergency room, from using the optimal large volume of irrigation fluid.
Nor does the prior art teach, as provided in a feature of my invention, a method of controllably causing a stable angled flow down a linear space. And there is no teaching, as provided in my invention, of a construction permitting and enhancing that an angled flow of a device can be rocked back and forth for providing an effective angular irrigation stream. Another disadvantage of a perpendicularly angled stream is that the force, when in using a plunger device, is pressing down directly on the skin. In general, there are no lateral forces in a consistent direction that would ease the movement of the device from one region of a wound to another, particularly in a linear wound. Another drawback of the prior art is that there is no teaching of a vent or relief feature (as in my instant invention), for more safe and efficient suction of excess irrigation fluid; and there is no teaching of such a device with a suction-powered removal system with a vent or relief feature that would prevent a full suction from occurring when the device's base forms a firm seal against a body surface. Such a suction force without a relief feature could pull the skin up into the device and cause damage and deformity to what might already be injured tissue.
Further, one standard type of container of sterile fluid (such as saline) in medicine is an “IV bag”, which may contain sterile normal saline solution. The IV bags are compressible and therefore one could propel fluid through the outlet and onto a wound. But prior devices using IV bags for irrigation suffer the lack (provided as a feature of my present invention) of a barrier to restrain splashed fluid. Such barriers are more and more generally used in medicine due to the risk of blood-borne disease such as HIV. And using connectors between such devices has numerous limitations. Assembling the devices together by the available friction fits requires time. Multiple separate devices might need to be unloaded out of sterile containers, resulting in increased time for the procedure, increased waste of packaging, increased cost of packaging and increased risk of the parts or the users breaking sterile protocols. In addition, vigilance during the procedure is required to assure that the devices do not disconnect. If such a disconnect occurred during a procedure unexpectedly, this would lead to a dangerous situation where a clinician might be exposed to a patient's bodily fluids and or where fluid might drench a patient or hospital room. This problem of disconnecting may be particularly a problem with the use of a compressible IV bag, as the act of manual compression requires a significant amount of force and might leave a user's hands shaky and unstable causing the assembled unit to be moved around quite a bit, possibly separating the unit apart.
Another limitation of the prior art is that the devices that do have splash shields have only one aperture for injection and therefore allow for only one size of jet stream. It is common to have many user preferences in wound irrigation. Some might prefer a quicker, lower-pressure higher-volume large-aperture injection and others might prefer a slower, higher-pressure lower-volume narrower-aperture injection. Prior art devices only allow for one type of injection stream through a single aperture. Or such devices can accept different IV catheter hub and tubing assemblies with different diameters to vary the pressure and flow; but this method requires additional assembly and the use of additional costly sterile packaging with disadvantages such as those described above. Others in the prior art use a single injection inlet with a complex mechanically powered water injection unit with a variable motor unit. This unit is costly and cumbersome and unlikely to be disposable. Its bulk makes it cumbersome for maneuvering on different parts of a patient's body. There is a lack of (as in my present invention) manually operated wound irrigation shields and injectors that have an inlet mechanism that allows for simple variation of injection flow to easily accommodate for user preferences. Such a device is needed and would gain broader acceptance and use; and it would reduce the stocking of multiple models or parts and would eliminate the need for assembly of connectors. Nor do any of these (as in my present invention for eliminating the problems set forth in this paragraph) have such a mechanism using IV spikes as connector inlets. Nor do any of these have a mechanism using an IV spike as a connector and having grooves or protrusions for stabilizing the interface between the squeeze bag or tube such as an IV bag and the shielding device. Nor do they have any means for improving the gripping means, or providing a flat surface for pivoting the injection stream. Nor do any of these have such a mechanism using a single part with an irrigation shield. Nor do any of these mechanisms have connectors that fit inside the already standardized fluid container outlets. Current wound irrigation shields fit over the fluid container outlets of the device; and the increased diameter increases the visual obstruction caused by the connection. Even minor increases in diameter can be of significance for wound irrigation shields that are small relative to the size of the fluid container which may already be causing a visual obstruction.
In the area of wound irrigation, the current art of syringes requires that one use a syringe with a limited volume multiple times to draw up irrigation fluid and then expel it. If a larger volume syringe is desired to reduce the time-consuming and cumbersome steps of drawing up fluid and expelling it, the syringe diameter is limited by the size of an irrigation container opening. As previously described, re-sealable irrigation containers, such as bottles, are preferable to open basins or baths. It is also desirable to have a single hand operated syringe so a second hand may be stabilizing other equipment such as a splash shield. Prior art limits the dimension of a single hand operated syringe used in an irrigation procedure with a re-sealable irrigation fluid container to be of a dimension with a barrel width narrower than the irrigation fluid container and a length less than a single hand span. Current art does not teach having a larger volume syringe for this purpose, or more specifically having a longer single hand operated syringe with a simple plunger delivery of the reservoir contents.
Another disadvantage of the prior art in the delivery of contents is the delivery of contents that require a higher pressure to deliver. Examples are fluids such as normal saline that is pushed through a small aperture under high pressure for improved irrigation results, or high viscosity fluids, including a slurry of activated charcoal to be delivered through a tube to a patient with an overdose. As syringes are hand operated, when a hand, including a fully extended thumb and gripping fingers are extended and intended to contract to operate the syringe, it is in a less stable position than in a less than extended or contracted position. It is therefore desirable to have a syringe that reduces the instability of a hand operated syringe delivering contents under high pressure when the plunger is an extended (including fully extended) position. Unfortunately, the prior art does not address this need adequately, and syringes that require high pressure often require two hands for operation to maintain stability—or possibly require the device to be placed against the body. If one attempts at addressing this concern by having improved gripping means on the barrel of the syringe and at the end of the syringe plunger, when the syringe is in a fully extended position, the system is still relatively unstable, especially when high pressure is necessary to hand operate the device. Additionally, if the syringe were of a length greater than one hand length, the syringe could not be operated by one hand and would therefore require more manipulations to operate.